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EN 14348:2005

Current
Current

The latest, up-to-date edition.

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
Published date

19-01-2005

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
  5.1 Principle
  5.2 Materials and reagents
  5.3 Apparatus and glassware
  5.4 Preparation of test organism suspensions and
       product test solutions
  5.5 Procedure for assessing the mycobactericidal
       activity of the product
  5.6 Experimental data and calculation
  5.7 Verification of methodology
  5.8 Expression of results and precision
  5.9 Interpretation of results - conclusion
  5.10 Test report
Annex A (informative) Referenced strains in national
                      collections
Annex B (informative) Suitable neutralizers
Annex C (informative) Graphical representations of the
                      test method
Annex D (informative) Example of a typical test report
Annex E (informative) Information on the application
                      and interpretation of European standards
                      on chemical disinfectants and antiseptics
Annex ZA (informative) Clauses of this document addressing
                       essential requirements or other
                       provisions of EU Directives
Bibliography

This document specifies a test method and the minimum requirements for mycobactericidal (or tuberculocidal) activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.This document applies to products that are used in the medical area including those that are covered by the EEC/93/42 Directive on Medical Devices.This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:- in hospitals, in community medical facilities and in dental institutions;- in clinics of schools, of kindergardens and of nursing homes;and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.NOTE 1The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.NOTE 2This method corresponds to a phase 2, step 1 test (see Annex E).

Committee
CEN/TC 216
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

ISO 15883-7:2016 Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
DIN EN ISO 15883-7 E : 2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
BS EN ISO 15883-7:2016 Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
BS EN 16616:2015 Chemical disinfectants and antiseptics. Chemical-thermal textile disinfection. Test method and requirements (phase 2, step 2)
UNI EN 12353 : 2013 CHEMICAL DISINFECTANTS AND ANTISEPTICS - PRESERVATION OF TEST ORGANISMS USED FOR THE DETERMINATION OF BACTERICIDAL (INCLUDING LEGIONELLA), MYCOBACTERICIDAL, SPORICIDAL, FUNGICIDAL AND VIRUCIDAL (INCLUDING BACTERIOPHAGES) ACTIVITY
BS EN 12353:2013 Chemical disinfectants and antiseptics. Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
DIN EN ISO 15883-4:2009-09 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
DIN EN 14885:2015-11 CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
DIN EN ISO 15883-4:2016-07 (Draft) WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
CSA Z15883-5:09 (R2019) Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (Adopted ISO/TS 15883-5:2005, first edition, 2005-11-15)
PREN 14885 : DRAFT 2014 CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
CAN/CSA-ISO 15883-7:17 Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (Adopted ISO 15883-7:2016, first edition, 2016-02-01)
CSA Z15883-5:2009 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
BS EN 14885:2015 Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics
EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
DIN EN 12353:2013-04 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
UNE-EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
I.S. EN 12353:2013 CHEMICAL DISINFECTANTS AND ANTISEPTICS - PRESERVATION OF TEST ORGANISMS USED FOR THE DETERMINATION OF BACTERICIDAL (INCLUDING LEGIONELLA), MYCOBACTERICIDAL, SPORICIDAL, FUNGICIDAL AND VIRUCIDAL (INCLUDING BACTERIOPHAGES) ACTIVITY
DIN EN 14885 E : 2015 CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
13/30281963 DC : 0 BS EN 16616 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - CHEMICAL-THERMAL TEXTILE DISINFECTION - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
14/30235350 DC : 0 BS EN ISO 15883-7 - WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT
BS EN ISO 15883-4:2009 Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
07/30090385 DC : 0 ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
CSA Z15883-4 : 2009 Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008, IDT)
ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
I.S. CEN ISO TS 15883-5:2006 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
CEN ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
UNE-EN 14885:2016 Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
I.S. EN 14885:2015 CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
EN 14885:2015 Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
DIN EN 16616:2015-10 Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
14/30294479 DC : 0 BS EN 14885 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
16/30288024 DC : 0 BS EN ISO 15883-4 - WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
I.S. EN ISO 15883-4:2009 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
I.S. EN 16616:2015 CHEMICAL DISINFECTANTS AND ANTISEPTICS - CHEMICAL-THERMAL TEXTILE DISINFECTION - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
I.S. EN ISO 15883-7:2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
EN ISO 15883-4:2009 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
EN 16616:2015 Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
DIN EN ISO 15883-7:2016-10 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
UNE-EN 16616:2015 Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
DIN EN 16616 E : 2015 CHEMICAL DISINFECTANTS AND ANTISEPTICS - CHEMICALTHERMAL TEXTILE DISINFECTION - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
UNE-EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
UNI EN ISO 15883-4 : 2009 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER- DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
CSA Z15883-4 : 2009 : R2014 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
CSA Z15883-5 : 2009 : R2014 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY

EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
EN 14820:2004 Single-use containers for human venous blood specimen collection

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